Polycystic Ovary Syndrome Clinical Trial
Official title:
Efficacy of Canagliflozin Versus Metformin in Women With Polycystic Ovary Syndrome Combined With Non-Alcoholic Fatty Liver Disease: A Single-center, Open-labeled Prospective Randomized Controlled
The goal of this clinical trial is to investigate the use of ultra-high performance liquid chromatography-mass spectrometry for metabolomics and proteomics research in patients with Polycystic Ovary Syndrome (PCOS) and Non-Alcoholic Fatty Liver Disease (NAFLD). The main questions it aims to answer are: - How can this technology help identify specific biomarkers for diagnosing PCOS combined with NAFLD? - What is the role of Canagliflozin in improving the safety and efficacy of treatment for PCOS and NAFLD patients? Participants, who are 50 non-diabetic women with PCOS, will undergo a series of assessments including cardiovascular metabolic indicators, liver NAFLD screening risk stratification, and insulin resistance index. They will be compared with 50 age and BMI-matched healthy controls. The participants will be randomized to receive either CANA/MET (Canagliflozin 100 mg daily plus Metformin 1000 mg twice daily) or MET (Metformin 1000 mg twice daily) for a continuous period of three months. The study will evaluate various parameters including menstrual patterns, anthropometric parameters, gonadal parameters, glucose-lipid homeostasis, liver enzyme indices, non-invasive hepatic fat changes, metabolomics, and NAFLD-related indicators.
Objective: 1. This study employs the latest ultra-high performance liquid chromatography-mass spectrometry platform for metabolomics and proteomics research to analyze serum samples from patients with Polycystic Ovary Syndrome (PCOS) coexisting with Non-Alcoholic Fatty Liver Disease (NAFLD). The aim is to identify specific biomarkers for the diagnosis of PCOS combined with NAFLD. At the same time, this study explores the pathogenesis and potential new therapeutic targets of PCOS combined with NAFLD at the protein and metabolic levels. 2. The study examines the role of Canagliflozin in improving the safety and efficacy of PCOS and NAFLD patients, providing evidence for the use of SGLT2 inhibitors as an effective treatment for PCOS with NAFLD. Methods: The study enrolled 50 non-diabetic PCOS women and assessed cardiovascular metabolic indicators including liver NAFLD screening risk stratification, insulin resistance index, etc. These were compared with 50 age and BMI-matched healthy controls. Utilizing the latest ultra-high performance liquid chromatography-mass spectrometry platform for metabolomics and proteomics research, a diagnostic model for PCOS coexisting with NAFLD was established and evaluated. The 50 patients were randomized 1:1 to receive Canagliflozin/Metformin or Metformin treatment. The Canagliflozin/Metformin group received Canagliflozin 100 mg once daily plus metformin 1000 mg twice daily, and the metformin group received Metformin 1000 mg twice daily, for a continuous period of three months. The study assessed the safety and efficacy of PCOS and NAFLD patients. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03142633 -
MicroRNA as Biomarkers for Development of Metabolic Syndrome in Women With Polycystic Ovary Syndrome
|
||
| Completed |
NCT06158932 -
A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance
|
N/A | |
| Completed |
NCT03644524 -
Heat Therapy and Cardiometabolic Health in Obese Women
|
N/A | |
| Active, not recruiting |
NCT02500147 -
Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS)
|
Phase 4 | |
| Completed |
NCT04932070 -
Berberine and Polycystic Ovary Syndrome
|
N/A | |
| Suspended |
NCT03652987 -
Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
|
||
| Completed |
NCT03480022 -
Liraglutide 3mg (Saxenda) on Weight, Body Composition, Hormonal and Metabolic Parameters in Obese Women With PCOS
|
Phase 3 | |
| Active, not recruiting |
NCT03043924 -
Functional Study of the Hypothalamus in Magnetic Resonance Imaging (MRI) in Polycystic Ovary Syndrome (PCOS)
|
N/A | |
| Completed |
NCT05246306 -
Aerobic Capacity and Physical Fitness Level of Adolescents With PCOS
|
||
| Completed |
NCT05981742 -
Effects of Combined Metformin and Cabergoline in Comparison With Metformin Only Therapy on Ovarian and Hormonal Activities in Iraqi Patients With PCOS
|
Phase 2 | |
| Completed |
NCT05702957 -
Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome
|
Phase 2/Phase 3 | |
| Completed |
NCT05029492 -
Effect of Visceral Manipulation on PCOS
|
N/A | |
| Completed |
NCT02924025 -
Motivational Interviewing as an Intervention for PCOS
|
N/A | |
| Not yet recruiting |
NCT02255578 -
Endobarrier Treatment in Women With PCOS
|
Phase 3 | |
| Withdrawn |
NCT01638988 -
Clomifene Citrate Versus Metformin in First-line Treatment of Infertility in Patients With Polycystic Ovary Syndrome and a Resistance to Insulin
|
Phase 3 | |
| Not yet recruiting |
NCT00883259 -
Metformin and Gestational Diabetes in High-risk Patients: a RCTs
|
Phase 4 | |
| Completed |
NCT02098668 -
Mathematical Model for the Human Menstrual Cycle, Endocrinological Diseases and Fertility Treatment-PAEON
|
N/A | |
| Completed |
NCT01462864 -
Development of a Structured Education Programme for Women With Polycystic Ovary Syndrome
|
N/A | |
| Recruiting |
NCT01431352 -
Letrozole Versus Chinese Herbal Medicine on Polycystic Ovary Syndrome (PCOS)
|
N/A | |
| Completed |
NCT00989781 -
Mechanisms of Increased Androgen Production Among Women With Polycystic Ovary Syndrome
|
N/A |